Found 6124 events where Vaccine is PNC13

VAERS ID: 453294 (history)   Vaccinated: 0000-00-00 Age: 0.4   Onset: 0000-00-00 Gender: Male   Submitted: 2012-02-28 Location: Foreign   Entered: 2012-04-10, Days after submission: 41	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Prematurely born boy with GA 26 weeks. Diagnostic Lab Data: Virus examinations for the most common viruses were negative. CDC 'Split Type': E201108476
Vaccination Manufacturer Lot Dose Route Site DTAPIPV: DTAP + IPV (FOREIGN) GLAXOSMITHKLINE BIOLOGICALS     UN UN HIBV: HIB (ACTHIB) SANOFI PASTEUR     UN UN PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH     UN UN
Administered by: Unknown     Purchased by: Unknown Symptoms: Nasopharyngitis, Rhinorrhoea, Viral test negative SMQs: Write-up: Case found in newsletter published on the web of the Health Authorities on 15-Dec-2011. Case medically confirmed. This case is linked to E2011-08471 and E2011-08475 (published on HA''s web concerning the same vaccines). A 5,5-month-old male patient had received an injection of ACT-HIB (batch number not reported) and concomitantly with DI-TE-KI-POL (other MFR, batch number not reported) and PREVENAR 13 (other mfr, batch number not reported) on an unspecified date and 4 days later on he developed nasopharyngitis with mucus production necessitating hospitalisation. Virus examinations for the most common viruses were negative. The boy is a premature baby with GA 26 weeks. At the time of reporting, the patient had recovered (date not reported). No causality assessment was reported. No further information expected.
VAERS ID: 453212 (history)   Vaccinated: 2012-04-04 Age: 4.0   Onset: 0000-00-00 Gender: Male   Submitted: 2012-04-06 Location: Florida   Entered: 2012-04-09, Days after submission: 3	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? Yes Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: None Preexisting Conditions: Asthma Diagnostic Lab Data: CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site DTAPIPV: DTAP + IPV (KINRIX) GLAXOSMITHKLINE BIOLOGICALS AC20B196CA 1 UN LL MMR: MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 1122AA 2 UN RL PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH F27291 4 UN RL VARCEL: VARICELLA (VARIVAX) MERCK & CO. INC. 1250AA 2 UN LL
Administered by: Private     Purchased by: Unknown Symptoms: Injection site erythema SMQs:, Extravasation events (injections, infusions and implants) (broad) Write-up: Redness on both injection sites, on thighs - 1 day after vacc.
VAERS ID: 453219 (history)   Vaccinated: 2012-03-28 Age: 4.0   Onset: 2012-03-29, Days after vaccination: 1 Gender: Female   Submitted: 2012-03-30, Days after onset: 1 Location: California   Entered: 2012-04-09, Days after submission: 10	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: No Preexisting Conditions: NKDA - none. Diagnostic Lab Data: None CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site MMR: MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 0518AA 1 SC LA PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH 916921 4 IM LA
Administered by: Private     Purchased by: Public Symptoms: Body temperature increased, Local swelling, Pain SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow) Write-up: Local, swelling & pain, mild tactile temperature.
VAERS ID: 453220 (history)   Vaccinated: 2012-03-30 Age: 1.0   Onset: 2012-04-05, Days after vaccination: 6 Gender: Male   Submitted: 2012-04-09, Days after onset: 4 Location: Georga   Entered: 2012-04-09	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Amoxicillin Current Illness: Otitis media Preexisting Conditions: Diagnostic Lab Data: None CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site HEPA: HEP A (HAVRIX) GLAXOSMITHKLINE BIOLOGICALS AHAVB534AA 0 IM LL MMR: MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 0852AA 0 SC LL PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH 916978 3 UN RL VARCEL: VARICELLA (VARIVAX) MERCK & CO. INC. 1058AA 0 UN RL
Administered by: Private     Purchased by: Public Symptoms: Rash generalised SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow) Write-up: Received MMR 3-30-12 - broke out in rash all over 4-5-12.
VAERS ID: 453222 (history)   Vaccinated: 2012-03-28 Age: 0.2   Onset: 2012-03-29, Days after vaccination: 1 Gender: Male   Submitted: 2012-04-07, Days after onset: 9 Location: Texas   Entered: 2012-04-09, Days after submission: 2	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? Yes Hospitalized? No Previous Vaccinations: Other Medications: None Current Illness: None Preexisting Conditions: None Diagnostic Lab Data: CBC (normal) CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) GLAXOSMITHKLINE BIOLOGICALS AC21B329BA 0 IM RL HIBV: HIB (PEDVAXHIB) MERCK & CO. INC. 1476AA 0 IM LL PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH F75398 0 IM LL ROTH1: ROTAVIRUS (ROTARIX) GLAXOSMITHKLINE BIOLOGICALS A41FB214A 0 PO
Administered by: Private     Purchased by: Private Symptoms: Full blood count normal, Pyrexia SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad) Write-up: Fever 102 began 12 hours after vaccines. Lasted 72 hours.
VAERS ID: 453233 (history)   Vaccinated: 2012-01-17 Age: 0.4   Onset: 2012-02-05, Days after vaccination: 19 Gender: Female   Submitted: 2012-04-09, Days after onset: 63 Location: Michigan   Entered: 2012-04-09	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? Yes Hospitalized? No Previous Vaccinations: Other Medications: None Current Illness: no Preexisting Conditions: no Diagnostic Lab Data: CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) SANOFI PASTEUR C4045AA 1 IM RL PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH 916599 1 IM LL ROTHB5: ROTAVIRUS (ROTATEQ) MERCK & CO. INC. 0508Z 1 PO
Administered by: Private     Purchased by: Public Symptoms: Haematochezia SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad) Write-up: Blood in stools. Patient was taken into hospital on 02/05/12. From there they were taken to another hospital who had the pt taken by ambulance to the final Hospital.
VAERS ID: 453253 (history)   Vaccinated: 2012-03-27 Age: 1.5   Onset: 2012-03-27, Days after vaccination: 0 Gender: Female   Submitted: 2012-03-29, Days after onset: 2 Location: Indiana   Entered: 2012-04-09, Days after submission: 11	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? Yes Hospitalized? No Previous Vaccinations: Other Medications: None Current Illness: None known Preexisting Conditions: Diagnostic Lab Data: Rapid RSV (-); Rapid flu (-); H/H = 12/34; WBC 10,000 with 58% neutrophils; 27% lymphs CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) SANOFI PASTEUR C399AA 3 UN RL MMR: MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 0741Z 0 UN LL PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH F12055 3 UN LL VARCEL: VARICELLA (VARIVAX) MERCK & CO. INC. 1318Z 0 UN RL
Administered by: Private     Purchased by: Public Symptoms: Febrile convulsion, Influenza virus test negative, Lymphocyte percentage, Neutrophil percentage, Pyrexia, Respiratory syncytial virus test negative, White blood cell count normal SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow) Write-up: Pt spiked a fever then had a febrile seizure about 6-8 hours after vaccines were given.
VAERS ID: 453268 (history)   Vaccinated: 2012-03-28 Age: 1.0   Onset: 2012-03-29, Days after vaccination: 1 Gender: Male   Submitted: 2012-04-02, Days after onset: 4 Location: New York   Entered: 2012-04-09, Days after submission: 7	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: None Preexisting Conditions: None Diagnostic Lab Data: CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH F56177 3 IM RA
Administered by: Private     Purchased by: Private Symptoms: Injection site erythema, Injection site induration SMQs:, Extravasation events (injections, infusions and implants) (broad) Write-up: (R) deltoid area with redness in distribution of band aid; above & underlying induration - minimal.
VAERS ID: 453271 (history)   Vaccinated: 2012-03-23 Age: 0.4   Onset: 2012-03-24, Days after vaccination: 1 Gender: Female   Submitted: 2012-03-30, Days after onset: 6 Location: Illinois   Entered: 2012-04-09, Days after submission: 10	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: None Current Illness: None Preexisting Conditions: Diagnostic Lab Data: CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) SANOFI PASTEUR 4204AA 1 IM UN PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH F75398 1 IM UN ROTHB5: ROTAVIRUS (ROTATEQ) MERCK & CO. INC. 1534AA 1 PO
Administered by: Private     Purchased by: Private Symptoms: Diarrhoea, Frequent bowel movements SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow) Write-up: Loose stools 4-5 times/day. Started day after ROTATEQ.
VAERS ID: 453272 (history)   Vaccinated: 2012-03-26 Age: 4.0   Onset: 0000-00-00 Gender: Male   Submitted: 2012-03-27 Location: California   Entered: 2012-04-09, Days after submission: 13	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: None Preexisting Conditions: Pt. had febrile seizure 2 years ago - NOT vaccine related Diagnostic Lab Data: CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site HEP: HEP B (ENGERIX-B) GLAXOSMITHKLINE BIOLOGICALS AHBVB972AA 2 IM RL HEPA: HEP A (HAVRIX) GLAXOSMITHKLINE BIOLOGICALS AHAVB534AA 1 IM RL HIBV: HIB (ACTHIB) SANOFI PASTEUR UH414AB 3 IM LL IPV: POLIO VIRUS, INACT. (IPOL) SANOFI PASTEUR E0950 2 SC LL MMR: MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 0873AA 1 SC RL PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH 916976 0 IM LL
Administered by: Private     Purchased by: Unknown Symptoms: Chills, Nausea, Pyrexia SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow) Write-up: Fever 103, chills, nausea lasting 3-4 hrs. Returned to clinic for re-check, seemed well. Phone follow up next day - well.
VAERS ID: 453203 (history)   Vaccinated: 0000-00-00 Age: 2.0   Onset: 0000-00-00 Gender: Female   Submitted: 2012-04-06 Location: Foreign   Entered: 2012-04-09, Days after submission: 3	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Therapy regimen changed; Unknown number of doses but administered according to the national guidelines Diagnostic Lab Data: CDC 'Split Type': 2012082765
Vaccination Manufacturer Lot Dose Route Site PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH     UN UN
Administered by: Unknown     Purchased by: Unknown Symptoms: Bacterial pericarditis, Pericardial excision, Pneumococcal infection, Pneumonia, Vaccination failure SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad) Write-up: This is a spontaneous report from a contactable physician. A female patient of an unspecified age received the first dose of PREVENAR 13 on an unknown date. Relevant medical history includes therapy regimen changed from PREVENAR to PREVENAR 13 on an unknown date. Concomitant medication were not provided. Past vaccine history includes an unknown number of doses of PREVENAR according to the national guidelines (dates and number of doses of each immunisation were not provided). In 2011, at the age of 2 years, the patient developed pneumonia and was hospitalized. While in the hospital, the patient developed pneumococcal pericarditis. Pneumococcus was identified to belong to one of the serotypes covered by PREVENAR 13 reported to be vaccination failure. Treatment consisted of a pericardiectomy. Relevant laboratory data was unknown. On an unknown date in 2011 the patient was discharged from the hospital and considered recovered from the events. No follow-up attempts needed. No further information expected.
VAERS ID: 453205 (history)   Vaccinated: 2012-01-10 Age: 0.3   Onset: 2012-01-10, Days after vaccination: 0 Gender: Male   Submitted: 2012-04-04, Days after onset: 84 Location: Foreign   Entered: 2012-04-09, Days after submission: 5	Life Threatening? Yes Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Born at 24 weeks and 5 days; Premature baby less than 26 weeks; From hyaline membrane disease, Cardio-respiratory distress; Primary apnea of premature newborns; Neonatal jaundice associated with preterm delivery; Patent ductus arteriosus; Retinopathy of prematurity; Right lower lip hemangioma; Hemangioma; Transient thrombocytopenia; Thrombocytopenia; Anemia of prematurity Diagnostic Lab Data: 11-JAN-2012, C-reactive protein, 4.22 mg/dl; 11-JAN-2012, CSF cell count, 4 /mm3; 11-JAN-2012, CSF glucose, 39 mg/dl; 11-JAN-2012, CSF protein, 75 mg/dl; 11-JAN-2012, Haematocrit, 29.9%; 11-JAN-2012, Haemoglobin, 9.5 g/dl; 11-JAN-2012, Platelet count, 365000 /mm3; 11-JAN-2012, Red blood cell count, 3350 /mm3; 11-JAN-2012, White blood cell count, 13380 /mm3; CSF chloride (12Jan2012): 114 mEq/l; Blood culture (11Jan2012): negative; Urine culture (11Jan2012): 1000000 UFC/ml multiple bacterial morphotypes from probable contamination CSF culture (12Jan2012): negative. Nose-pharyngeal aspirate (12Jan2012): negative for respiratory syncytial virus (RSV); Nose-pharyngeal aspirate (16Jan2012): negative for respiratory syncytial virus (RSV), Adenovir CDC 'Split Type': 2012082447
Vaccination Manufacturer Lot Dose Route Site 6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN) GLAXOSMITHKLINE BIOLOGICALS A21CB186B 0 IM UN PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH F43114 0 IM UN
Administered by: Unknown     Purchased by: Unknown Symptoms: Abdominal X-ray, Adenovirus test, Apnoeic attack, Blood chloride, Blood culture negative, Blood product transfusion, Bradycardia, C-reactive protein increased, CSF cell count, CSF culture negative, CSF glucose decreased, CSF protein increased, Chest X-ray normal, Clonus, Condition aggravated, Cough, Culture urine positive, Dyspnoea, Echography normal, Electroencephalogram normal, Endotracheal intubation, Extubation, Haematocrit decreased, Haemoglobin decreased, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Mechanical ventilation, Oxygen saturation decreased, Platelet count normal, Red blood cell count decreased, Respiratory syncytial virus test negative, White blood cell count normal, X-ray normal SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (broad) Write-up: This is an initial spontaneous report received from the Regulatory Authority. Regulatory Authority report number 162743. A physician (contactable through Regulatory Authority only) reported that a 3-month-old male patient received a first dose of PREVENAR 13 intramuscularly on 10Jan2012 and first dose of INFANRIX HEXA intramuscularly on 10Jan2012 during hospitalization. Medical history included premature baby (the patient was born at 24 weeks and 5 days), cardio-respiratory distress from hyaline membrane disease, infantile apnoeic attack, jaundice neonatal, patent ductus arteriosus, retinopathy of prematurity, right lower lip hemangioma, transient thrombocytopenia and anaemia neonatal. The patient''s concomitant medications were not reported. The patient experienced bradycardia and apnea attack on 10Jan2012. The case was assessed as life-threatening. After a few hours post-vaccination a worsening of general condition and appearance of episodes of apnea and desaturation were observed and a c-reactive protein with micromethod (increased) and septic screening (negative) were performed. Antibiotic therapy was initiated. In the following hours, due to the persistence of apnea episodes associated with bradycardia, the patient was intubated and assisted ventilation continued for about 24 hours and transfusion of packed red cells for anemia was arranged. After extubation, non-invasive ventilation was necessary to continue for several days. By microbiological culture and chest X-ray results, there was no clear localization of a specific pathogen focus; however a possible infection of the airways could be assumed due to respiratory effort and cough symptoms. For the appearance of clonus of upper limb, an ultrasound of brain and EEG monitoring were performed which showed no pathological alterations. From 19Jan2012, the patient fed entirely at bottles. On 23Jan2012, administration of prophylaxis against respiratory syncytial virus (RSV) infection with Palizumab was performed. The patient underwent c-reactive protein (4.22 mg/dl) on 11Jan2012, CSF cell count (4 /mm3) on 11Jan2012, CSF glucose (39 mg/dl) on 11Jan2012, CSF protein (75 mg/dl) on 11Jan2012, Haematocrit (29.9 %) on 11Jan2012, Haemoglobin (9.5 g/dl) on 11Jan2012, platelet count (365000/mm3) on 11Jan2012, red blood cell count (3350 /mm3) on 11Jan2012, white blood cell count (13380 /mm3) on 11Jan2012, CSF chloride (114 mEq/l) on 12Jan2012, Blood culture (negative) on 11Jan2012), Urine culture (1000000 UFC/ml multiple bacterial morphotypes from probable contamination) on 11Jan2012, CSF culture (negative) on 12Jan2012, Nose-pharyngeal aspirate (negative for respiratory syncytial virus (RSV)) on 12Jan2012, Nose-pharyngeal aspirate (negative for respiratory syncytial virus (RSV), Adenovirus, Influenza A and B, and para-influenza virus) on 16Jan2012, Cerebral echography (within normal range) on 13Jan2012. Chest-abdomen X-ray (broncho pneumonic foci are not evident) on 11Jan2012. EEG (within normal range) on 13Jan2012. The child was in good conditions, without showing regular episodes of desaturation. The patient recovered from the events. No follow-up attempts needed. No further information expected.
VAERS ID: 453206 (history)   Vaccinated: 2012-01-24 Age: 1.2   Onset: 2012-01-24, Days after vaccination: 0 Gender: Male   Submitted: 2012-04-05, Days after onset: 71 Location: Foreign   Entered: 2012-04-09, Days after submission: 4	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Unknown Diagnostic Lab Data: CDC 'Split Type': 2012082392
Vaccination Manufacturer Lot Dose Route Site MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) GLAXOSMITHKLINE BIOLOGICALS     IM UN PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH     IM UN
Administered by: Unknown     Purchased by: Unknown Symptoms: Crying, Gait disturbance, Screaming, Weight bearing difficulty SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad) Write-up: This is a spontaneous report from a practice nurse via the contactable foreign Medicines Board. Regulatory authority reference number is 2012-009520. A 14-month-old male patient of unknown race received a dose of PREVENAR 13 and a dose of PRIORIX, both given at 0.5 ml unit dose intramuscularly into right thigh on 24Jan2012. The patient''s relevant medical history was not reported. The patient was not receiving any concomitant medications. On 24Jan2012, the patient woke from sleeping screaming, crying and unable to weight bear which lead to difficulty walking. No corrective treatment was required in response to the events. It was stated that the duration of the events was 3 hours the patient recovered from the events on an unknown date. The reporter considered the events to be serious as they were thought to be medically important conditions. The agency considered the events to be serious due to an unspecified reason. No follow-up attempts possible. No further information expected.
VAERS ID: 453207 (history)   Vaccinated: 0000-00-00 Age: 0.7   Onset: 0000-00-00 Gender: Male   Submitted: 2012-04-05 Location: Foreign   Entered: 2012-04-09, Days after submission: 4	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Unknown Diagnostic Lab Data: Blood culture (2011): Streptococcus pneumoniae, serotype 19A CDC 'Split Type': 2012078926
Vaccination Manufacturer Lot Dose Route Site PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH   1 UN UN
Administered by: Unknown     Purchased by: Unknown Symptoms: Blood culture positive, Empyema, Pneumonia pneumococcal, Streptococcus test positive, Vaccination failure SMQs:, Lack of efficacy/effect (narrow) Write-up: This is a spontaneous report from a contactable physician. A 9-month-old male patient received the third dose of PREVENAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. The patient was not a premature baby and is a healthy infant. The patient previously received the first and second doses of PREVENAR 13 at the ages of 6-month-old and 7-months-old, respectively. At the age of 9-months-old, the patient experienced pneumococcal pneumonia and thoracic empyema on an unspecified date in 2011 (reported as 26 days after the last vaccination). Streptococcus pneumoniae, serotype 19A was detected by blood culture. The outcome of the events was unknown. A possible sequelae pleural fibrosis was noted. Follow-up attempts completed. No further information expected.
VAERS ID: 453208 (history)   Vaccinated: 2010-01-29 Age: 0.3   Onset: 2010-03-01, Days after vaccination: 31 Gender: Unknown   Submitted: 2012-04-05, Days after onset: 765 Location: Foreign   Entered: 2012-04-09, Days after submission: 4	Life Threatening? Yes Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Diagnostic Lab Data: EEG (sleep and awake) (date unknown): brain organic disease excluded; Cranial MRI (date unknown): brain organic disease excluded; Lipid metabolism disorder (date unknown): metabolic disorder excluded CDC 'Split Type': 2012083647
Vaccination Manufacturer Lot Dose Route Site 6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN) GLAXOSMITHKLINE BIOLOGICALS A21CA620A 1 IM UN PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH E195518 1 IM UN
Administered by: Unknown     Purchased by: Unknown Symptoms: Electroencephalogram normal, Epilepsy, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow) Write-up: This is a spontaneous report downloaded from the web-portal of a foreign Health Authority under Regulatory Authority report number DE-PEI-PEI2012009924. A 3-month-old patient received the second dose of PREVENAR 13 (lot # E19528) and the second dose of INFANRIX HEXA (lot # A21CA620A) on 29Jun2010. Relevant medical history and concomitant medications were not reported. Past vaccine history includes: the first dose of PREVENAR 13 and the first dose of INFANRIX HEXA administered on 28Dec2009 at the age of 2 months. The vaccines were well tolerated. On 01Mar2010, at the age of 4 months, the patient experienced epilepsy. The child was hospitalized and the event was classified as life-threatening. In the hospital blood samples were taken and examinations were performed. Tests included sleep and awake EEG, cranial MRI and lipid metabolism disorder test. Brain organic disease and metabolic disorder were excluded. The outcome of the event was resolved with sequelae (not specified) on an unknown date. No follow-up attempts needed, follow-up automatically provided by PEI.
VAERS ID: 453157 (history)   Vaccinated: 2012-03-02 Age: 1.0   Onset: 2012-03-13, Days after vaccination: 11 Gender: Female   Submitted: 2012-04-08, Days after onset: 26 Location: New York   Entered: 2012-04-08	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: no Preexisting Conditions: no Diagnostic Lab Data: CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site HIBV: HIB (ACTHIB) SANOFI PASTEUR UH391AA 3 IM RL MMR: MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 0807AA 0 SC LL PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH 916979 3 IM RL
Administered by: Unknown     Purchased by: Private Symptoms: Urticaria SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow) Write-up: Patient developed generalized body urticaria.
VAERS ID: 453124 (history)   Vaccinated: 2012-03-27 Age: 3.0   Onset: 0000-00-00 Gender: Female   Submitted: 2012-04-05 Location: Texas   Entered: 2012-04-06, Days after submission: 1	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: None Current Illness: None Preexisting Conditions: None Diagnostic Lab Data: Cellulitis and abscess of leg/vaccine reaction CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH F62923 4 IM RL
Administered by: Private     Purchased by: Public Symptoms: Abscess limb, Cellulitis, Erythema, Pruritus, Swelling, Vaccination complication SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad) Write-up: Date of Service: 3/31/12. Two days after received PVC13 on the right thigh. Did not notice any redness or swelling until this AM. No pain. Itches a little. No fever. NO drainage. Ambulating well. Patient was Rx BACTRIM PO susp. 200mg 40/5ml. BENADRYL BID as needed. Motrin/Tylenol for pain.
VAERS ID: 453160 (history)   Vaccinated: 2012-03-02 Age: 0.2   Onset: 2012-03-09, Days after vaccination: 7 Gender: Male   Submitted: 2012-04-06, Days after onset: 27 Location: Maryland   Entered: 2012-04-06	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? Yes Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: None Preexisting Conditions: Prematurity 36 week gestation Diagnostic Lab Data: None CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) GLAXOSMITHKLINE BIOLOGICALS AC218325EA 0 UN LL HIBV: HIB (ACTHIB) SANOFI PASTEUR UH483AA 0 UN RL PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH 918172 0 UN LL ROTHB5: ROTAVIRUS (ROTATEQ) MERCK & CO. INC. 0922AA 0 PO
Administered by: Private     Purchased by: Private Symptoms: Diarrhoea haemorrhagic SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad) Write-up: Two episodes of bloody diarrhea.
VAERS ID: 453180 (history)   Vaccinated: 2012-04-05 Age: 4.0   Onset: 2012-04-06, Days after vaccination: 1 Gender: Male   Submitted: 2012-04-06, Days after onset: 0 Location: California   Entered: 2012-04-06	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? Yes Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: None Preexisting Conditions: Diagnostic Lab Data: CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site DTAPIPV: DTAP + IPV (KINRIX) GLAXOSMITHKLINE BIOLOGICALS AC20B193DA 0 IM LA MMR: MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 1293AA 1 SC RA PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH 917242 4 IM RA VARCEL: VARICELLA (VARIVAX) MERCK & CO. INC. 1274AA 1 SC LA
Administered by: Other     Purchased by: Public Symptoms: Injection site erythema, Injection site oedema SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow) Write-up: Bilat. lateral deltoid erythematous and edematous. BENADRYL given as tx.
VAERS ID: 453033 (history)   Vaccinated: 2012-04-03 Age: 58.0   Onset: 2012-04-03, Days after vaccination: 0 Gender: Female   Submitted: 2012-04-04, Days after onset: 1 Location: North Carolina   Entered: 2012-04-05, Days after submission: 1	Life Threatening? No Died? No Permanent Disability? No Recovered? Yes ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: LIPITOR Current Illness: None Preexisting Conditions: High cholesterol Diagnostic Lab Data: CDC 'Split Type':
Vaccination Manufacturer Lot Dose Route Site PNC13: PNEUMO (PREVNAR13) PFIZER/WYETH F88044 0 IM RA
Administered by: Other     Purchased by: Other Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow) Write-up: Colleague began with soreness at the injection site on 4-3-12 about 5 pm. This morning (4-14-12) at 0300, she had swelling at the site, fatigue, and chills. She took ADVIL at 0330 and 1330 (400 mg each time). Feels back to normal other then swelling.